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Samsung Biologics Co., Ltd. — FDA Facility Profile

FEI 3010479596

Samsung Biologics Co., Ltd. is an FDA-registered facility (FEI 3010479596) located in South (KOR). Registered operations: ANALYSIS; API MANUFACTURE; LABEL; PACK. RegDataLab tracks 4 FDA inspections at this facility.

Facility Details

Location
South (KOR)
Registration Expires
December 31, 2026
Operations
ANALYSIS; API MANUFACTURE; LABEL; PACK
Source
decrs

Recent inspections

  • 1218067 (VAI Fri Sep 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1201856 (VAI Tue Feb 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1108244 (VAI Fri Nov 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1056899 (VAI Tue Jun 26 2018 00:00:00 GMT+0000 (Coordinated Universal Time))

Import refusals

  • NUV-3855286-8/70002/1 (Tue Nov 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 788-1799197-5/11/1 (Wed Jun 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 788-1775925-7/11/1 (Fri Sep 16 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources